All, many of you have commented on this post seeking an update for human trials of Minnelide. As we mentioned previously, we’re working with the FDA and regulatory bodies on the processes of human trials and we’re on pace to begin those trials later this year. We will update the public as soon as we have a solid timeframe and enrollment details.”

-Justin Paquette, Academic Health Center Office of Communications

Update 1/3/13:

“Currently, our application to begin Minnelide clinical trials is under review by the FDA, and we continue to provide all materials and information requested to support that review. Our research team is hopeful approval will be granted, allowing us to move ahead with Minnelide trials in the late spring or early summer of 2013. As we advance through the FDA approval process, we will continue to keep interested parties updated.” – Edward Greeno, M.D., medical director of the Hematology/Oncology clinic at the University of Minnesota. Greeno will be the principle investigator for the phase I trial of Minnelide.

Original text:

A new drug created at the University of Minnesota may hold the answer to defeating pancreatic cancer, according to results published today in the prestigious journal Science Translational Medicine.

The study is based on successful outcomes in a mouse model – results researchers hope to carry over to human patients when the drug potentially begins human trials sometime in 2013.

The drug, Minnelide, is a type of injectable chemotherapy designed to target tumor cells. The drug works by inhibiting a heat shock protein, HSP 70, which has been proven to aid the growth of tumor cells. By stopping HSP 70 from working, Minnelide disperses the cells integral to the tumor’s growth and the cancer disintegrates.

The drug is based on patented technology designed in the Masonic Cancer Center labs of Ashok Saluja, Ph.D., professor and vice chair of research in the University of Minnesota Medical School’s Department of Surgery, Selwyn Vickers, M.D., chairman of the Department of Surgery, and Gunda Georg, Ph.D., director of the Institute for Therapeutics Discovery and Development in the College of Pharmacy. Bruce Blazar, M.D., director of the Center for Translational Medicine, also partnered on this project.

Pancreatic cancer is the most lethal of all cancers. This year alone, more than 44,000 Americans will be diagnosed with the disease and the median survival time following a pancreatic cancer diagnosis is just six months.

“A diagnosis of pancreatic cancer is incredibly grim. There is no good way to treat or cure this particular type of cancer,” said Saluja, who holds the Eugene C. and Gail V. Sit Chair in Pancreatic and Gastrointestinal Cancer Research, “and the best options currently available offer just six weeks of added survival. It is far from tackling the real problem which is that pancreatic cancer tumor cells make survival proteins, rendering them increasingly difficult to defeat.”

In 2007, Saluja and his collaborators discovered pancreatic cancer cells have too much HSP 70, which protects cells from dying. Because of this excess protein, pancreatic cancer cells are difficult to target with drugs, meaning the logical next step in fighting the cancer was to determine how to inhibit HSP 70 in these tumor cells.

Saluja found that triptolide, a compound derived from plants in China, worked to halt the development of HSP 70 in tumor cells, but because triptolide is not water soluble, it was still difficult to administer to patients. The Institute for Therapeutics Discovery and Development at the University of Minnesota, in collaboration with the Saluja lab, worked to make triptolide water soluble. They named their drug Minnelide as a nod to the compound from which it was derived, triptolide, and its discovery location, the University of Minnesota.

The University of Minnesota holds the patent on the modifying factors that create Minnelide from triptolide. It has been licensed to Minneamrita Therapeutics LLC for production.

Funding for this research was provided by NIH grants R01CA124723 and R01 CA170496, as well as the Katherine and Robert Goodale Foundation and the Hirshberg Foundation.

The University of Minnesota Medical School, with its two campuses in the Twin Cities and Duluth, is a leading educator of the next generation of physicians. Our graduates and the school’s 3,800 faculty physicians and scientists advance patient care, discover biomedical research breakthroughs with more than $180 million in sponsored research annually, and enhance health through world-class patient care for the state of Minnesota and beyond. Visit www.med.umn.edu to learn more.

Masonic Cancer Center, University of Minnesota is part of the University’s Academic Health Center. It is designated by the National Cancer Institute as a Comprehensive Cancer Center. For more information about the Masonic Cancer Center, visit www.cancer.umn.edu or call 612-624-2620.

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Comments

October 19, 2012 6:26 am | Don Baker Says:

If you need anyone to test this, let me know. I was diagnosed with pancreatic cancer 10 months ago. They tried surgery but it wasn’t successful and I’m now out of options and am willing to try anything.

Don, thanks for your comment. Like many of our discoveries, this one is in the pipeline heading toward human trials but our researchers believe it won’t be possible to test in humans until Spring 2013. It is being reviewed by the FDA. Until then, I would advise checking http://www.clinicaltrials.gov for a comprehensive list of all trials – available nationwide – that focus on pancreatic cancer. I’m sorry this current approach isn’t yet available, but hopefully the clinicaltrials.gov resource will help you find something your physicians find appropriate.

I understand the need to have new drugs approved by the FDA but most people don’t have time to wait until Spring 2013. Is there anything that can be done to speed up this process. We are from Minnesota and would welcome the chance to try this drug on an experimental basis.

I’ve been under treatment for Islet Cell cancer of the pancreas for over 3 1/2 years now, with Adriamyacin, Streptozocin, 12 cycles of Sutent and am on the 2nd. cycle of Afinitor–there were also 28 radiation treatments.

All, since we’ve gotten a few comments about human trials: as we mentioned in the post, we’re working with the FDA to determine when we’ll be able to shift this discovery into human trials. This particular research was done in a mouse model. We hope to launch trials in human patients sometime in 2013.

can my husband sign up for the human treatments? He was diagnosed with pancreatic cancer 7/15/11 and has been fighting ever since. This sounds like our only hope! Please let us know how we can sign up to be a patient. thanks!!

Laurie – I’m sorry to hear about your husband’s battle with pancreatic cancer. There is no human trial for Minnelide yet; our doctors are working with the FDA to see when such a trial is possible. We’re hopeful this would be sometime in 2013. This needs to go through existing government/approval processes. For a list of current trials active for pancreatic cancer, check out http://www.clinicaltrials.gov. I hope you and your husband are able to find a path to potential treatment.

My husband been diagnose with pancreatic cancer August, 2011, Been treated in Mayo Clinic with Jemzar and Abraxane for 4 mths. Return in Canada had 28 radiation and chemo, recently finish 4 cycles of 2 Jemzar. I think now,that his only hope with the new drug (Minnelide)
They say in one article in the news paper, they discover that herb Minnelide in China. Do you know if they using (Minnelide) in China to treat pancreatic cancer? I they do, could you give me more information? We would go to China and my husband would be ready to try.

My mother was able to take abraxane / gemcitabine combo and had good results. She was diagnosed one year ago today with stage 4 adenocarcinoma of the pancreas and she is still holding it in check with folfox. She was able to take the Abraxane combo off study as it was just entering phase III with good results. Is it possible to take a drug off study that is in phase I?

Becky, there is no firm timetable for any approval from the FDA. Our best current estimate is that we’re hopeful human trials can begin in 2013. I’m sorry we don’t have a better timeline. This, like any other trial or product, is subject to government oversight and approval.

My dad has been recently diagnosed with pancreatic cancer with 2.9cm in mid December. Recently he under went surgery 4-Jan-2013 and they have found that the tumour has grown to 5.5cm and is not operatable with the tumor stuck on some vain. Any chance to have this trial tested in Australia?

My husbund was diagnosed with a pancreatic tumor on top and into some veins. They were going to do the whipple surgery but got in and closed him back up and could not do it. He is doing chemo again but we are out of options. He will die without something new. We will try anything.It will be a year this June. Please help us!!!

My sister is running out of options. She is not even 50 years old. She was diagnosed July 2011 (the same week our mother lost her battle with pancreatic cancer). My sister did chemo & radiation and had an aborted Whipple due to lung Mets. The Mets disappeared for awhile but came back as of this month. She is otherwise healthy and extremely active, would be a great candidate for a trial. Is the FDA any closer to approval? It is now spring 2013……

Wife my has been diagnosed with pancreatic cancer, we have been told that surgry is not an option, she is under going a course of chemo therapy but we have been told that the prognosis is not good, we are desperate and very interested in taking part in trials of minnelide.
We are able and willing to travel at short notice, it looks like this may be our only hope.
My wife is 59 and resently retired from teaching

Such a promising looking drug that provides HOPE against a type of cancer that has such a TERRIBLE prognosis! To all those interested in seeing this drug get accelerated approval, you can try reaching out to the FDA Special Health Issues department.

The FDA Office of Special Health Issues (OSHI) is a liaison between the FDA and patients, patient advocates, and health professional organizations. The OSHI responds to inquiries and concerns related to cancer, and provides information about the FDA drug approval process and clinical trials.

My husband was diagnosed with metastatic adenocarcinoma. We will start chemotherapy in two weeks. Surgery in not an option because of cell in the liver. I want to know has the trials started and would my husband be a good candidate?

My husband was diagnosed with pancreatic cancer last Thursday. I came across this clinical study and am very interested in getting more information ASAP, as he is to start chemo treatments Monday, July 1. I need to know what the requirements are and can we get him registered if he is a candidate. I am also sending a message to his oncologist to obtain feedback, based on his results and diagnosis. I hope to hear from you soon, as we are very overwhelmed, anxious and nervous at the same time, wanting to do what is best for him. Thank you so much!

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